ApprovalTrail

Medical device licence · 100398 · Class 3

BILILUX

Yes: licensed in Canada

Licence status Issued (active); first licensed January 16, 2018. It is in Health Canada’s list of active licences.
Licence number
100398
Licence holder
Draeger Medical Systems, Inc.Danvers, MA, United States
Risk class
Class III (moderate to high risk)
Licence type
Single Device
First licensed
January 16, 2018
Devices covered
1

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • BILILUX

Recalls and safety alerts that mention it

Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “bililux”. A notice may cover another product or only some lots: read it to see what it covers.

  • BililuxMay 10, 2022 · General hospital and personal use · Manufacturing defect · Type II
  • BiliLux (2019-08-21)January 10, 2020 · Medical devices · Medical devices · Type II

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.